I think the other issue is that in order to seek FDA approval, you must declare that your nicotine product, is a smoking cessation product. The FDA currently does not offer any regulation to any product that contains nicotine that is not intended to get you to quit smoking/nicotine use. You must have clinical trials that prove over a certain amount of time, people not only stop using
tobacco, but they stop using your product all together.
Then, you must go back and re-evaluate those persons after a certain amount of time to see who has gone back to
tobacco cigarettes and who has not. From there, you would be able to seek approval based on whether your product actually does get people to quit smoking or not.
This would also produce a length of time for product use, ie: the gum is a step down program that is used over the course of 8 weeks. Also, Chantix can only be taken for a specific amount of time. The patch also uses a time frame for usage. All of these time frames fall under "suggested usage".
Now, as far as the elimination of any liquids over 24mg, this is being done according to the manufacturers because of the dosage. From what I gathered with our conversations with Health Canada before they made their recent ruling, that anything containing more than 4mg per dose is considered a prescription drug. It is my understanding that this also holds true for the FDA as well.
We were just having this conversation as to why someone hasn't come out with a gum that has nicotine in it that doesn't claim anything other than "you can have nicotine where you can't smoke". Would it be allowed? It would be, however, it would have the same fight that nicotine water had and that we are having now and that is fighting the philosophy: If isn't for quitting smoking and it's a "bridge" product or alternative, it should not be allowed.
IMHO, I feel there are those within the FDA who are truly torn about this and are in this for public health. They do see a valid public health solution and if we can all just give it a bit more time, let them get through the lawsuit with SE, we might be able to make a bit more traction with them when they are not on the defensive, which they are right now. There was headway being made with the FDA via several suppliers UNTIL the SE lawsuit. Then all discussions were put on hold... obviously.
If the FDA had wanted to actually ban the electronic cigarette, (and I still firmly believe that they couldn't/can't, but could have just because), then they would have done it in September of 2008 when the World Health Organization made the warning very clear, that the ecig is not a proven quit smoking device. Very few American's would have known what was happening and all PV users would have gone way underground OR gone back to tobacco. There were also only a handful of suppliers at the time so the "stink" would have been minimal and easily swept under the carpet.
But the fact is that they didn't.
You are right. There is a way to work with the FDA. And maybe one of the best things that could have happened is the Tobacco Bill. They are going to have their hands full with the regulation of the tobacco industry and we all know that if they are truly a public health organization with true intentions, then they will be open to a new product that still falls outside of the regulatory regulations of both tobacco and drugs. The industry itself has to prove that it is a cash cow, just like tobacco and pharmaceuticals and that will level the playing field for a fair regulatory scheme that does not force the electronic cigarette into the "quit" category... which is not where it belongs.
On the other hand, all of this testing that needs to be done, could very well be happening... but I don't think any of the big manufacturers are actually going to tell the world what they are doing, until it is done. It's all about emerging first and to give your competition the heads up... well that's silliness.
